510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900002Substantially Equivalent

Doppler Option for Platinum

Philips North America LLC, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900002 is the FDA 510(k) clearance record for DOPPLER OPTION FOR PLATINUM, a class II device, cleared for Philips Medical Systems North America, Inc. on under FDA product code DXK (Echocardiograph). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K900002.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DXK Echocardiograph
Regulation
21 CFR 870.2330
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medical Systems North America, Inc. 2722 S. Fairview St., Santa Ana CA
Third party review
No

Clearances, product code DXK

Trailing 12 months

FDA records hold no clearances under product code DXK in the trailing twelve months.

FDA records show no clearances under product code DXK in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260